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Last Updated: December 22, 2024

ESTROGEL Drug Patent Profile


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Which patents cover Estrogel, and when can generic versions of Estrogel launch?

Estrogel is a drug marketed by Ascend Theraps Us and is included in one NDA.

The generic ingredient in ESTROGEL is estradiol. There are seventy-five drug master file entries for this compound. Forty-nine suppliers are listed for this compound. Additional details are available on the estradiol profile page.

DrugPatentWatch® Litigation and Generic Entry Outlook for Estrogel

A generic version of ESTROGEL was approved as estradiol by BARR LABS INC on October 22nd, 1997.

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Drug patent expirations by year for ESTROGEL
Drug Sales Revenue Trends for ESTROGEL

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Recent Clinical Trials for ESTROGEL

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SponsorPhase
FundaciĆ³n Santiago Dexeus FontPhase 3
Hamad Medical CorporationPhase 2
Laboratoires Besins InternationalPhase 2

See all ESTROGEL clinical trials

Pharmacology for ESTROGEL
Drug ClassEstrogen
Mechanism of ActionEstrogen Receptor Agonists

US Patents and Regulatory Information for ESTROGEL

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Ascend Theraps Us ESTROGEL estradiol GEL, METERED;TRANSDERMAL 021166-002 Feb 9, 2004 AB RX Yes Yes ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Ascend Theraps Us ESTROGEL estradiol GEL;TOPICAL 021166-001 Feb 9, 2004 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

ESTROGEL Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory of Estradiol Gel (ESTROGEL)

Introduction

Estradiol gel, a key component of hormone replacement therapy (HRT), is experiencing significant growth in the global market. This growth is driven by increasing demand for treatments addressing menopausal symptoms and other hormonal imbalances. Here, we will explore the market dynamics and financial trajectory of estradiol gel, particularly focusing on its market size, growth drivers, regional dynamics, and financial performance.

Market Size and Growth

The global estradiol gel market was valued at US$ 79 million in 2023 and is anticipated to reach US$ 127 million by 2030, with a compound annual growth rate (CAGR) of 7.3% during the forecast period 2024-2030[1][3].

Forecasted Market Size

  • The market is expected to grow from US$ 79 million in 2023 to US$ 127 million by 2030, indicating a robust expansion in the coming years.

CAGR

  • The CAGR of 7.3% highlights the steady and significant growth anticipated in the estradiol gel market.

Drivers of Growth

Increasing Incidence of Menopausal Symptoms

The rising incidence of menopausal symptoms such as hot flashes, vaginal dryness, and mood swings is a primary driver of the estradiol market. As women live longer and remain more active into later life stages, the demand for treatments that alleviate these symptoms is on the rise[1][3].

Changing Cultural Views

Shifting cultural views toward women's health and menopause are also contributing to market growth. Menopause is increasingly seen as a normal stage of life rather than a disease, leading to greater acceptance and use of HRT products like estradiol gel[1][3].

Aging Population

The aging population, particularly in regions like North America, Europe, and the Asia-Pacific, is another significant factor. Countries such as South Korea and Japan, with rapidly aging populations, are expected to drive market expansion as more women seek effective treatments for menopausal symptoms[1][3].

Regional Market Dynamics

North America

North America is a well-established market for estradiol products, driven by a high number of women experiencing menopause and a strong healthcare infrastructure that supports industry growth. The region benefits from a high level of awareness about hormone replacement treatments and a robust healthcare system[1].

Europe

Europe also sees significant demand due to its aging population and progressive views on women's health. The region's healthcare infrastructure further supports the market expansion, making it a key market for estradiol gel[1].

Asia-Pacific

The Asia-Pacific region offers substantial growth opportunities, particularly in countries like South Korea and Japan. As awareness of menopausal health issues and HRT increases, the demand for estradiol products is expected to rise. Improvements in healthcare infrastructure and regulatory environments are also expected to propel market growth in this region[1].

Key Players and Competitive Landscape

The estradiol gel market is dominated by several major pharmaceutical companies, including:

  • Vertical Pharmaceuticals, LLC
  • Meda Pharmaceutical
  • Ascend Therapeutics
  • Abbott
  • BSV Group
  • Wuhan Jianmin Group[1]

These companies are investing heavily in research and development to enhance their product offerings and expand their market share.

Financial Performance

Revenue and Sales

The financial performance of companies in the estradiol market is robust, with significant revenue growth. For example, the launch of new generic products, such as ANI Pharmaceuticals' Estradiol Gel, 0.06%, enters a market with annual sales of approximately $16.7 million, according to August 2024 IQVIA data. This indicates the potential for substantial revenue generation in the segment[5].

Research and Development

Investments in research and development are also driving financial growth. Companies are focusing on new products and approvals, which contribute to increased revenues and profitability. For instance, investments in clinical stage assets and biosimilars are expected to enhance the financial performance of companies in the estradiol market[2][3].

Market Segments

The estradiol gel market is segmented by type, application, and geography.

Types

  • Skin Administration
  • Vaginal Administration[1]

Applications

  • Pharmacy Sales
  • Online Sales[1]

Regulatory Environment

The approval of new products, such as ANI Pharmaceuticals' Estradiol Gel, 0.06%, which received FDA approval, highlights the importance of regulatory clearances in the market. Such approvals ensure the entry of new products into the market, enhancing competition and accessibility for patients[5].

Challenges and Opportunities

Challenges

  • Despite the growth, the market faces challenges such as side effects associated with long-term usage of hormone replacement therapies. These side effects can include hot flashes, night sweats, and vaginal dryness, which may affect widespread customer acceptance[4].

Opportunities

  • The increasing awareness about hormonal treatments and menopausal health issues presents significant opportunities for market growth. The aging population and progressive views on women's health are expected to drive demand for estradiol gel and other HRT products[1][3].

Key Takeaways

  • The estradiol gel market is growing significantly due to increasing demand for HRT.
  • The market is driven by the rising incidence of menopausal symptoms, changing cultural views, and an aging population.
  • North America, Europe, and the Asia-Pacific are key regions driving market growth.
  • The competitive landscape includes several major pharmaceutical companies.
  • Financial performance is robust, with significant revenue growth and investments in R&D.
  • Market segments are defined by type, application, and geography.

FAQs

Q: What is the current market size of the global estradiol gel market?

  • The global estradiol gel market was valued at US$ 79 million in 2023[1].

Q: What is the anticipated CAGR for the estradiol gel market from 2024 to 2030?

  • The estradiol gel market is anticipated to witness a CAGR of 7.3% during the forecast period 2024-2030[1].

Q: Which regions are driving the growth of the estradiol gel market?

  • North America, Europe, and the Asia-Pacific are key regions driving market growth[1].

Q: Who are the main players in the estradiol gel market?

  • The main players include Vertical Pharmaceuticals, LLC, Meda Pharmaceutical, Ascend Therapeutics, Abbott, BSV Group, and Wuhan Jianmin Group[1].

Q: What are the primary drivers of the estradiol gel market?

  • The primary drivers include the rising incidence of menopausal symptoms, changing cultural views toward women's health, and an aging population[1][3].

Sources

  1. Global Estradiol Gel Market Research Report 2024 - Valuates Reports
  2. Organon Reports Results for the Fourth Quarter and Full Year Ended December 31, 2022 - Organon
  3. Generic ESTRADIOL INN entry, drug patent expiration information - Drug Patent Watch
  4. Estrogen Blockers Market Size, Trends and Forecast to 2030 - Coherent Market Insights
  5. ANI Pharmaceuticals Announces the FDA Approval and Launch of Estradiol Gel, 0.06% - Stock Titan

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